Perspectives in clinical research
-
Ethics committee meetings are held periodically, with all members being physically present in the meeting room. During the COVID-19 pandemic, and the lockdown, a number of committees have resorted to the use of videoconferencing. Online meetings have significant advantages over physical or face-to-face meetings, though the guidelines and regulations imply that online meetings should not be the norm. Considering the advantages of online meetings in terms of saving time and costs, can the regulations and guidelines be tweaked to allow them even after the lockdown is over?
-
Global pandemic of COVID-19 is a serious unmet medical need requiring clinical research into effective therapies. Clinical trials during pandemics of infections face complex challenges of putting scientific and ethical principles into practice. Some of these issues - selection of investigational product and participants, study design, assessment of efficacy and safety, ethics review, informed consent and publication, sample size, and publications - require in-depth consideration in planning and implementation of clinical trials during pandemics.
-
Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulatory and safety domains, understanding of research methodologies, and awareness of relevant regulations and guidelines. ⋯ However, the current share of India in global medical writing business is very small. This industry in India faces some real challenges, such as the lack of depth and breadth in domain expertise, inadequate technical writing skills, high attrition rates, and paucity of standardized training programs as well as quality assessment tools. Focusing our time, attention, and resources to address these challenges will help the Indian medical writing industry gain its rightful share in the global medical writing business.
-
The aim of this study was to identify the publication speed (peer review time and publication time) of biomedical Indian journals and identify the journals having the facility of advance online publication (AOP). ⋯ Overall, the peer review time and publication time of biomedical Indian journals included in our study seems to be fairly long. Less than one-third of biomedical Indian journals provide the facility of AOP.
-
The medical writing industry is on an upwards growth path in India. This is probably driven by an increasing urgency to have high-quality documents authored to support timely drug approvals, complemented by the realization that the competencies required are available in emerging geographies such as India. This article reviews the business landscape and the opportunities and challenges associated with outsourcing medical writing work India. It also analyzes the core competencies that a medical writer should possess and enlists various associations supporting learning in this domain.